Blood Markers Study for People at Higher Risk of Early Pancreas Cancer

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults at higher than average risk of pancreatic cancer: people with new diabetes or high-risk pre-diabetes, a pancreatic cyst or chronic pancreatitis, or an inherited risk.

Age

19 years or older

Sex

All sexes can join.

Disease stage

Must fit at least one group: new type 2 diabetes diagnosed within the past 3 years or high-risk pre-diabetes; a pancreatic cyst needing surgery, endoscopic ultrasound or repeat imaging, or chronic pancreatitis; or inherited risk (two or more blood relatives with pancreatic cancer, one close relative diagnosed before age 60, or a gene change linked to higher risk).

Earlier treatment

People who took metformin for pre-diabetes for 3 years or more cannot join. People currently treated for cancer cannot join (long-term hormonal therapy is not counted).

Biomarker or test result

For the inherited risk group, a gene change linked to higher pancreatic cancer risk, for example BRCA1, BRCA2, PALB2, MLH1, MSH2, MSH6, PMS2, APC, CDKN2A, STK11, ATM, SMAD4, BMPR1A, TP53 or CFTR.

Main reasons for not taking part

• Has had pancreatic ductal adenocarcinoma (a type of pancreatic cancer)
• Currently receiving treatment for cancer (long-term hormonal therapy excluded from this rule)
• Pre-diabetes treated with metformin for 3 years or more
• Cannot give written informed consent
• Cannot attend in-person visits in Omaha, NE twice a year for blood samples

The registry criteria, word for word

What the trial wants to find out

Identifying biomarkers of early pancreatic ductal adenocarcinoma (PDAC) could facilitate screening for individuals at higher than average risk and expedite the diagnosis in individuals with symptoms and substantially improve an individual's chance of surviving the disease.

The 3 groups in the trial

• New Onset Diabetes/High-Risk Prediabetes

  Must meet one of the following criteria: 1. New onset type 2 diabetes diagnosed within the past 3 years, defined as Hemoglobin A1c ≥ 6.5%\*, fasting blood glucose \>126mg/dL confirmed on a subsequent day or as diagnosed by a physician 2. High-risk pre-diabetes: Hemoglobin A1c \>6.3% or A1c \>6.0% with fasting blood glucose \>110 or 2 hour oral glucose tolerance test between 140-200mg/dL; subjects who have been on metformin \<3 years are eligible

• Pancreatic Cystic Neoplasm/Pancreatitis

  Must meet one of the following criteria: 1. Pancreatic cystic neoplasm for which resection, endoscopic ultrasound or serial imaging has been recommended 2. Chronic pancreatitis as defined by cross-sectional imaging, endoscopic ultrasound, functional testing abnormalities OR as diagnosed by a gastroenterologist

• Inherited Risk

  Must meet one of the following criteria: 1. Two or more blood relatives with PDAC (includes 1st-3rd degree relatives as defined in Table 2) 2. One 1st degree relative with PDAC diagnosed before age 60 3. Germline mutation associated with a higher than average risk of PDAC including but not limited to the following: Hereditary breast and ovarian cancer syndromes BRCA1, BRCA2, PALB2 Hereditary nonpolyposis colon cancer (Lynch) syndrome MLH1, MSH2, MSH6, PMS2 Familial adenomatous polyposis (APC) Familial atypical multiple melanoma and mole syndrome CKDN2a, p16 Peutz-Jeghers syndrome STK11 Ataxia-telangiectasia ATM Juvenile polyposis syndromes SMAD4, BMPR1A Li Fraumeni TP53 Cystic fibrosis and unaffected carriers CFTR 4. Personal or family history which meets clinical criteria for a hereditary cancer syndrome and includes a relative with PDAC